Job Description Summary

Supervisor, Quality Services (12 months contract)

At Paladin Pharma, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment, Paladin is the place for you!

This position requires a presence at our office located in St-Laurent, Montreal, two days a week, on Tuesdays and Wednesdays.

Reporting to the Quality Services Manager, the Supervisor Quality Services is responsible for providing and leading quality systems at Paladin. This includes managing the deviations, CAPAs, complaints, product release and Mock recalls. The supervisor is involved in the change control system, management review, approval of GMP documentation and procedures. They also ensures the maintenance of compliance for all products and systems, and leads Quality support on assigned projects to maintain and improve Paladin’s systems and products.

This person works with cross-functional departments and suppliers for the completion of documentation related to our quality systems and batch release. They ensure compliance with current domestic and international GMPs and regulatory agencies.

Job Description

Quality Systems

• Contribute to the development, management, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP/ ISO 13485 activities.

• Assist with all aspects of quality systems, such as Change Control, Deviations, Investigations, complaints and CAPA systems to assure compliance and timely and accurate completion of reported events.

Batch Record / Reports Review

• Supervise the QA batch release functions for cGMP commercial and distribution activities from the contract manufacturing, filling, testing and packaging facilities, including non MRA requirements and product return process

• Prepare and/or review controlled documents (e.g. SOP's) required for compliance.

Management

• Supervise and coordinate quality services staff and/or consultants towards the timely completion of assigned duties and responsibilities.

Your Profile

• Bachelor’s degree in a health-related discipline or science.

• 5+ years’ experience working in a Quality role in a GXP environment in the pharmaceutical or medical device industry.

• 2+ years of experience with quality management systems.

• Thorough understanding of fundamental GXP/ ISO 13485 terminology, concepts, regulations and industry standards.

• Thorough understanding of quality systems and associated regulatory requirements and their application.

• Ability to identify and troubleshoot routine technical problems.

• Bilingual (French and English) with excellent oral and written communication skills in both languages*

Paladin Pharma strives to offer a French-speaking work environment to all its Quebec-based employees. Although, as part of its francization program, Paladin Pharma has taken all reasonable measures to avoid imposing the requirement of English, knowledge, and proficiency in English for Supervisor, Quality Services position is at an advanced level, particularly due to the need to communicate and collaborate regularly in English with English-speaking cross-functional departments and business partners outside the province of Quebec.

What We Offer

• Hybrid work schedule

• Benefits package on first day

• Retirement Savings Plan (RRSP)

• Employer contribution to employee RRSP (DPSP)

• Employee Assistance Program (EAP)

• Telemedicine program

• Employee Referral Program ($)

• Free gym on site

• Free parking

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

About Us:

Headquartered in Montreal, Canada, Paladin Pharma is a leading specialty pharmaceutical company focused on acquiring or in-licensing new pharmaceutical products for the Canadian market. Its dedicated employees have made Paladin one of Canada's pioneering specialty pharmaceutical companies.

Paladin is an operating company of Endo USA, Inc, a highly specialized pharmaceutical company that brings quality branded and generic products to patients through excellence in development, manufacturing, and marketing.

To learn more about us, visit our website at www.paladin-pharma.com/

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.